Ductal Carcinoma in SituDCISNCT05218044
Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
A study testing Cryoablation in people with Ductal Carcinoma in Situ, run by Glendale Adventist Medical Center d/b/a Adventist Health Glendale at 1 site in United States.
Trial summary
Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI
- Diagnosis of DCIS by minimally invasive needle biopsy
- No prior history of DCIS or invasive breast cancer in the same breast
- No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
- Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation
- Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
- No history of breast radiation in the same breast
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Office of Dennis R. Holmes, M.D., F.A.C.S.
Glendale, California, 91206
Dennis Holmes, M.D., 800-203-5515
Dennis Holmes, M.D.
About this study
Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.
- Conditions
- Ductal Carcinoma in Situ
- Being tested
- Cryoablation
- Keywords
- DCIS
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
The cryoprobe tip will be inserted into the breast and directed under ultrasound guidance to the location where the ultrasound visible marker is located. Next, the cryoprobe will be used to freeze a 4 X 3 X 3 cm diameter area of DCIS using two separate 10-minute freeze cycles separated by a single 10-minute thaw cycle. The cryoprobe will remain in place the entire time. After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Other | Phase I, single-arm study to evaluate the ability of cryoablation to achieve complete ablation of DCIS in the cryoablation zone of necrosis as a potential alternative to surgery. Receives: Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of cryoablation to achieve complete ablation of DCIS
Number of participants to achieve completeness of ablation by measuring the percentage of subjects with no residual DCIS or invasive cancer within the zero of necrosis assessed in the post-cryoablation core biopsy obtained 6 months post-cryoablation.
Measured: 6 months
Secondary outcomes (1)
Recurrence rate
Number of participants at the 5-year rate of invasive breast cancer recurrence after cryoablation of DCIS measuring </= 2cm.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glendale Adventist Medical Center d/b/a Adventist Health Glendale
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Rey Breast Cancer Research Foundation, California Oncology Research Institute, Doterra Healing Hands Foundation
- Responsible party
- Principal investigator, Dennis Holmes, Glendale Adventist Medical Center d/b/a Adventist Health Glendale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218044
- Sponsor's protocol ID
- DCIS Cryo
- Acronym
- DCIS
- Status last verified
- Mar 2023
- First submitted
- 23 Dec 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
- ClinicalTrials.gov ID
- NCT05218044
- Acronym / sponsor ID
- DCIS / DCIS Cryo
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- DCIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Glendale Adventist Medical Center d/b/a Adventist Health GlendaleUniversity, hospital or other
- Collaborators
- Helen Rey Breast Cancer Research Foundation, California Oncology Research Institute, Doterra Healing Hands Foundation
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Other | Procedure: CryoablationPhase I, single-arm study to evaluate the ability of cryoablation to achieve complete ablation of DCIS in the cryoablation zone of necrosis as a potential alternative to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI
- Diagnosis of DCIS by minimally invasive needle biopsy
- No prior history of DCIS or invasive breast cancer in the same breast
- No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
- Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationThe cryoprobe tip will be inserted into the breast and directed under ultrasound guidance to the location where the ultrasound visible marker is located. Next, the cryoprobe will be used to freeze a 4 X 3 X 3 cm diameter area of DCIS using two separate 10-minute freeze cycles separated by a single 10-minute thaw cycle. The cryoprobe will remain in place the entire time. After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin. | Procedure or surgery | Cryoablation |
Primary outcome
Ability of cryoablation to achieve complete ablation of DCIS
Time frame: 6 months
Number of participants to achieve completeness of ablation by measuring the percentage of subjects with no residual DCIS or invasive cancer within the zero of necrosis assessed in the post-cryoablation core biopsy obtained 6 months post-cryoablation.
1 secondary outcome
Recurrence rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Ductal Carcinoma in Situ, run by Glendale Adventist Medical Center d/b/a Adventist Health Glendale at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis R Holmes, M.D. (800-203-5515, drholmesmd50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of cryoablation to achieve complete ablation of DCIS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.